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United States · US · US:68084-572_1e137707-60f2-51ee-e063-6294a90afe82

Mucinex

Orange BookUNIISPLATC R05CA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeR05CA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808457201
    100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-572-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-572-11)

Annotations

UNII (FDA Substance ID)
495W7451VQ
GUAIFENESIN
RxCUI 5032
Orange Book
N021282
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "495W7451VQ",
    "rxcui": "5032",
    "inchikey": "HSRJKNPTNIJEKV-UHFFFAOYSA-N",
    "display_name": "GUAIFENESIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "49f1f415-8017-0974-e063-6294a90a8918": {
      "match": "brand_token",
      "title": "MUCINEX 12HR COLD AND FEVER MULTI-SYMPTOM (NAPROXEN SODIUM, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET, EXTENDED RELEASE [RB HEALTH (US) LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "68084-572_1e137707-60f2-51ee-e063-6294a90afe82",
  "productndc": "68084-572",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "021282",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Jul 12, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.2GM",
        "product_no": "002",
        "approval_date": "Dec 18, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "GUAIFENESIN",
  "proprietary_name": "Mucinex",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021282",
  "marketing_category": "NDA",
  "nonproprietary_name": "Guaifenesin",
  "start_marketing_date": "20160219",
  "active_numerator_strength": "600"
}

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